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Terminated

AW VolumeShare 4 (ADVANTAGE WORKSTATION 4.3.), AW VolumeShare 5 (AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION), AW Server. K052995: Advantage Workstation 4.3 is a review station, which allows easy selection, review, processing and filming of multi-modality DICOM images from a variety of diagnostic imaging systems. When interpreted by a trained physician, filmed or displayed images on the AW monitor may be used as a basis for diagnosis, except in the case of mammography images. K110834: AW VolumeShare 5 is a review workstation, which allows easy selection, review, processing and filming of multi-modality DICOM images from a variety of diagnostic imaging systems. When interpreted by a trained physician, filmed or displayed images on the AW monitor may be used as a basis of diagnosis, except in the case of mammography images. K081985: AW Server is a medical software system that allows multiple users to remotely access AW applications from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images. Both the client and server software are only for use with off the shelf hardware technology that meets defined minimum specifications.

FDA Recall Z-0270-2014 · Posted 2013-11-13

Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeLLZ
Date Initiated2013-09-19
Date Terminated2014-07-31
Product Quantity1458 (336 US, 1122 OUS)

Reason for Recall

GE Healthcare has recently become aware of a potential safety issue due to the image orientation within GSI viewer on AW products. The GSI Viewer application running on AW/Volume Share or on the AW Server when making a batch and rotating the batch group clockwise 180 degrees (Inferior to Superior) will display images in the Superior orientation. The orientation annotation on the image is correc

Firm Action

The firm, GE Healthcare, sent an "Urgent Medical Device Correction" letter dated September 19, 2013 to its consignees/customers. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information (800-437-1171 for USA and Canada or contact local GE Healthcare Applications Specialist). The customers were instructed to "Please ensure that all potential users in your facility are made aware of this safety notification and the action taken". GE Healthcare will provide a software update for all affected systems to address the issue. A GE Healthcare service representative will contact you to arrange for this correction. This activity will be performed at no cost to you. A second updated letter was sent on October 22, 2013 to correct the Affected Product Details communicated in the previous letter dated September 19, 2013. The new statement reads "All versions of GSI Viewer prior to version 2.00-OM on AW and prior to version 2.20- OB on AW Server are affected". If you have any questions, please contact us at 800-437-1171 (USA and Canada) or contact local GE Healthcare Applications Specialist.

Root Cause

Software design

Distribution Pattern

Worldwide distribution: US (nationwide) including states of: AL, AZ, CA, CT,DE, FL,GA, HI, IL, IN, IA, KS, MD,MA, MI,MN, MS, O. NV, NH, NJ, NY, NC, OH, OK, OR, PA, SD, TN, TX , UT, VA, WA, WI. OUS: ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, BYELO RUSSIAN, CANADA, CHINA, DENMARK, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, HONDURAS, HON KONG, HUNGARY, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KOREA, KUWAIT, LATVIA, LIBYA, LITHUANIA, LUXEMBOURG, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PORTUGAL, RUSSIA, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UKRAINE, and UNITED KINGDOM. .

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K110834AW VOLUMESHARE 5 WITH ANGIOVIZ OPTIONGE Healthcare · 2011-04-26K081985AW SERVERGe Medical Systems, LLC · 2008-09-25K052995ADVANTAGE WORKSTATION 4.3.GE Healthcare · 2005-11-08

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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